Stakeholder Insight: HIV - A way of life

Published by: Datamonitor

Published: Oct. 14, 2005 - 284 Pages

Table of Contents

About the Infectious Disease pharmaceutical analysis team

Scope of the analysis

Datamonitor insight into the HIV market

Coverage of the Stakeholder Insight Survey

Epidemiology

Diagnosis and treatment rates

Antiretroviral prescriptions

Prescription choice

Country level treatment trees

US

Japan

France

Germany

Italy

Spain

UK

Seven major markets

Disease definition and classification

The HIV lifecycle - numerous steps has created several therapeutic targets

HIV subtypes - diversity throughout the world

HIV epidemiology - changing demographics creating new unmet needs

A growing proportion of women are affected by HIV/AIDS

The aging of the HIV population has created new therapeutic issues

Key patient segmentations

Newly diagnosed versus follow-up patients

Multi-drug resistant patients

Hepatitis co-infection

Pregnancy

Routes of transmission

Presentation and diagnosis

Perception of risk drives HIV testing

HIV diagnostics are effective and easy to use

ELISA

PCR

Others

Advances in diagnostics has led to quicker and easier

HIV tests

Treatment guidelines

Treatment rates

Treatment options

Class overviews

First-line therapy

Prescription choice

FDC backbones dominate first-line therapy

Switching from first- to second-line therapy

Factors affecting patient quality of life are key drivers of regime changes

The M184V mutation is the most common in first-line patients, but NNRTI resistance is also a frequent driver of switching

Second-line therapy

Prescription choice

PI usage is more predominant in second-line therapy

Switching from second- to third-line therapy

Tenofovir- and PI-associated mutations are more common in second-line patients

Third- and later-line therapy

Prescription choice

Fuzeon is increasingly being used in third- and later-lines of therapy

Factors influencing prescription choice

Patient quality of life issues are playing an increasingly important role

Although a growing concern, cost rarely plays a part in the physician decision

The increasing importance of cost in prescription decisions

How cost-effective is HAART?

Cost of first-line therapy in the US and the UK - a comparison

Treatment outcomes

Advances in therapy mean fewer patients progress to AIDS

Morbidity and mortality have declined significantly over the last decade

HIV accounts for a small proportion of total deaths in the developed world

Antiretroviral therapy has led to significant gains in terms of survival years and a reduced incidence of opportunistic infections

Unmet needs

Resistance to currently available therapy is a major unmet need for certain classes

Although there have been considerable improvements in therapy, important unmet needs remain

French key opinion leader

Section 1 - Epidemiology

Section 2 - Presentation and diagnosis

Section 3 - Treatment practices

Section 4 - Prescription choice

Section 5 - Resistance issues

Section 6 - Unmet Needs

Section 7 - Pipeline products

Italian key opinion leader

Section 1 - Epidemiology

Section 2 - Presentation and diagnosis

Section 3 - Treatment practices

Section 4 - Prescription choice

Section 5 - Resistance issues

Section 6 - Unmet Needs

Section 7 - Pipeline products

German key opinion leader

Section 1 - Epidemiology

Section 2 - Presentation and diagnosis

Section 3 - Treatment practices

Section 4 - Prescription choice

Section 5 - Resistance issues

Section 6 - Unmet Needs

Section 7 - Pipeline products

US key opinion leader

Section 1 - Epidemiology

Section 2 - Presentation and diagnosis

Section 3 - Treatment practices

Section 4 - Prescription choice

Section 5 - Resistance issues

Section 6 - Unmet Needs

Section 7 - Pipeline products

Spanish key opinion leader

Section 1 - Epidemiology

Section 2 - Presentation and diagnosis

Section 3 - Treatment practices

Section 4 - Prescription choice

Section 5 - Resistance issues

Section 6 - Unmet Needs

Section 7 - Pipeline products

UK key opinion leader

Section 1 - Epidemiology

Section 2 - Presentation and diagnosis

Section 3 - Treatment practices

Section 4 - Prescription choice

Section 5 - Resistance issues

Section 6 - Unmet Needs

Section 7 - Pipeline products

US key opinion leader (cost efficiency expert)

Section 1 - Current cost of antiretroviral therapy

Section 2 - Pricing antiretrovirals

Pacific Rim definition

Journal articles

Conference abstracts

Press Releases

Websites

Guidelines

Epidemiological data

Physician research methodology

Physician sample breakdown

US

Japan

France

Germany

Italy

Spain

UK

The survey questionnaire

Section 1: Epidemiology

Section 2: Diagnosis and treatment rates

Section 3: Antiretroviral prescriptions

Section 4: Prescription choice

The opinion leader discussion guide

Section 1 - Epidemiology

Section 2 - Presentation and diagnosis

Section 3 - Treatment practices

Section 4 - Prescription choice

Section 5 - Resistance issues

Section 6 - Unmet needs

Section 7 - Pipeline products

Disclaimer

List of Tables

Table 1: Total number of patients treated by the SI physician sample compared to the total number of treated patients in each of the seven major markets

Table 2: HIV pipeline, 2005

Table 3: HIV prevalence and incidence numbers and rates, seven major markets, 2003

Table 4: Number of women, aged between 15 and 49, with HIV/AIDS, 2002 and 2004

Table 5: Incidence of new opportunistic infections and tumors according to age group (rate/1,000 person-years)

Table 6: Total number of newly diagnosed and follow-up HIV patients, seven major markets*, 2005

Table 7: Rate of problem drug use** in the five major European markets

Table 8: Total number of HIV patients with hepatitis B C infection, seven major markets, 2005

Table 9: Hepatotoxicity of antiretrovirals

Table 10: Reasons for seeking HIV testing among adults in the US, 1998 and 2002

Table 11: Total diagnosed HIV patient population in the seven major markets, 2005

Table 12: HIV treatment guidelines available for the seven major markets

Table 13: Examples of changes in the US DHHS guidelines since 1998

Table 14: Overview of the antiretrovirals available for the treatment of HIV

Table 15: Fixed-dose combinations: key facts

Table 16: Top five first-line antiretroviral regimes by patient numbers in the seven major markets, 2005, as reported by the SI physician sample

Table 17: Key safety concerns for Epzicom and Truvada

Table 18: Key antiretroviral side effects

Table 19: Reasons for missing antiretroviral doses

Table 20: Costs, clinical benefits and cost effectiveness of triple-drug antiretroviral regimes

Table 21: Cost per year of first-line antiretroviral therapy in the US, as recommended by the DHHS guidelines

Table 22: Cost per year of first-line antiretroviral therapy in the UK, as recommended by the BHIVA guidelines

Table 23: Survival benefits of antiretroviral therapy in the US

Table 24: Key pricing data for antiretrovirals in the US, 2004

Table 25: Key pricing data for antiretrovirals in the UK, 2005

Table 26: US physician sample breakdown

Table 27: Japan physician sample breakdown

Table 28: France physician sample breakdown

Table 29: Germany physician sample breakdown

Table 30: Italy physician sample breakdown

Table 31: Spain physician sample breakdown

Table 32: UK physician sample breakdown

List of Figures

Figure 1: Treatment trees calculation methodology

Figure 2: Calculation methodology for total number of patients on every regime for each line of therapy

Figure 3: HIV prevalence, diagnosis and treatment rates, and the proportion of patients on each line of therapy in the US

Figure 4: The percentage of patients on the top five antiretroviral regimes for each line of therapy in the US

Figure 5: HIV prevalence, diagnosis and treatment rates, and the proportion of patients on each line of therapy in Japan

Figure 6: The percentage of patients on the top five antiretroviral regimes for each line of therapy in Japan

Figure 7: HIV prevalence, diagnosis and treatment rates, and the proportion of patients on each line of therapy in France

Figure 8: The percentage of patients on the top five antiretroviral regimes for each line of therapy in France

Figure 9: HIV prevalence, diagnosis and treatment rates, and the proportion of patients on each line of therapy in Germany

Figure 10: The percentage of patients on the top five antiretroviral regimes for each line of therapy in Germany

Figure 11: HIV prevalence, diagnosis and treatment rates, and the proportion of patients on each line of therapy in Italy

Figure 12: The percentage of patients on the top five antiretroviral regimes for each line of therapy in Italy

Figure 13: HIV prevalence, diagnosis and treatment rates, and the proportion of patients on each line of therapy in Spain

Figure 14: The percentage of patients on the top five antiretroviral regimes for each line of therapy in Spain

Figure 15: HIV prevalence, diagnosis and treatment rates, and the proportion of patients on each line of therapy in the UK

Figure 16: The percentage of patients on the top five antiretroviral regimes for each line of therapy in the UK

Figure 17: HIV prevalence, diagnosis and treatment rates, and the proportion of patients on each line of therapy in the seven major markets

Figure 18: Total AIDS cases per year, seven major markets, 1993-2003

Figure 19: The HIV replication process

Figure 20: The classification and geographic distribution of HIV subtypes

Figure 21: Total HIV/AIDS patients by gender, seven major markets, 2001 and 2005

Figure 22: Age distribution of the HIV patient population, seven major markets, 2005

Figure 23: Total HIV diagnoses per year by age group, US, 2000-03

Figure 24: Percentage of newly diagnosed and follow-up HIV patients, seven major markets, 2005

Figure 25: Patients with phenotypic antiretroviral resistance, US

Figure 26: Triple class resistance in the UK, 1999-2002

Figure 27: Percentage of HIV patients with hepatitis B or C infection, seven major markets, 2005

Figure 28: Percentage of HIV patients acquiring the infection through intravenous drug use, seven major markets, 2005

Figure 29: Routes of HIV transmission in the seven major markets, 2005

Figure 30: New HIV infections acquired via sexual contact in the UK, 1990-2005

Figure 31: Usual test centers for HIV diagnosis, US

Figure 32: Diagnosis rate in the seven major markets, 2001 and 2005

Figure 33: Treatment guidelines recommendations for initial antiretroviral therapy

Figure 34: Treatment status of the diagnosed HIV population in the seven major markets, 2005

Figure 35: Antiretroviral market share (percentage of sales) by class, seven major markets, 2004

Figure 36: Antiretroviral market share (percentage of sales) by product, seven major markets, 2004

Figure 37: Total treated HIV patients on each line of therapy, seven major markets

Figure 38: Percentage of patients on each regimen, first-line therapy, as reported by the SI physician sample

Figure 39: The NRTI pill burden has been significantly reduced following the introduction of the FDCs

Figure 40: Percentage of first-line patients on each NRTI FDC, seven major markets, as reported by the SI physician sample

Figure 41: Factors leading to switching from first- to second-line antiretroviral therapy

Figure 42: Quality of life factors leading to switching from first- to second-line therapy

Figure 43: Frequency of tolerability issues and adverse effects leading to switching from first- to second-line therapy

Figure 44: The PIs most frequently cause adverse lipid effects in first-line therapy

Figure 45: Simple, personalized pill reminders can be provided on a pager, with two-way communication and information provision available on the more sophisticated devices

Figure 46: The Crixivan website provides a personalized pill planner for HIV/AIDS patients who are starting a new regime, including the option for selecting reminder activities

Figure 47: Percentage of patients switching from first- to second-line therapy due to resistance development, seven major markets

Figure 48: Prevalence of HIV drug resistance in the US

Figure 49: Resistance mutations commonly leading to switching from first- to second-line therapy

Figure 50: Percentage of patients on each regimen, second-line therapy, as reported by the SI physician sample

Figure 51: Percentage of second-line patients on NNRTI- and PI-based regimes and on each PI, as reported by the SI physician sample

Figure 52: Factors leading to switching from second- to third-line antiretroviral therapy

Figure 53: Resistance development exerts a greater influence in switching decisions for later-lines of therapy

Figure 54: The incidence of tenofovir- and PI-related mutations increases for second-line therapy

Figure 55: Percentage of patients on each regimen, third- and fourth/later-line therapy, as reported by the SI physician sample

Figure 56: Factors driving first-line antiretroviral prescription choice in the seven major markets

Figure 57: Factors affecting patient quality of life exert a strong influence over first-line prescription choice

Figure 58: Impact of product attributes on adherence

Figure 59: Cost is a relatively low priority in terms of influencing prescription choice

Figure 60: Timeline of the development of the HIV market

Figure 61: Total AIDS cases per year, seven major markets, 1991-2004

Figure 62: Total AIDS deaths per year in the US and UK, 1991-2005*

Figure 63: Infectious diseases as proportion of all deaths, 2001

Figure 64: Main causes of death in the UK, 2003 and the US, 2002

Abstract

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